Method of placing an implant between bone portions

ABSTRACT

Devices and methods for placing an implant between two bone portions are disclosed. In some embodiments, a method comprises disposing a portion of a flexible member through a first bone portion, through an aperture in a trial implant, and through a second bone portion. The trial implant can be withdrawn to enable an implant to be coupled to the flexible member. The method includes applying tension to the flexible member to urge the implant into the space between two bone portions. In some embodiments, the two bone portions are facets.

INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS

This application claims priority under 35 U.S.C. §119(e) to U.S.Provisional Patent Application No. 61/883,911, filed Sep. 27, 2013, thedisclosure of which is incorporated by reference herein in its entirety.This application incorporates by reference U.S. Pat. No. 8,740,949 (U.S.application Ser. No. 13/033,791, filed Feb. 24, 2011); U.S. PatentPublication 2012/0221049 (U.S. application Ser. No. 13/403,698, filedFeb. 23, 2012), U.S. Pat. No. 7,846,183 (application Ser. No.10/865,073, filed Jun. 10, 2004), U.S. Pat. No. 8,652,137 (U.S.application Ser. No. 12/035,366, filed Feb. 21, 2008), U.S. Publication2011/0040301 (application Ser. No. 12/859,009, filed Aug. 18, 2010), intheir entirety.

BACKGROUND

Some embodiments described herein relate generally to methods anddevices for facilitating the insertion of an implant between boneportions.

Some embodiments described herein relate generally to methods andimplants for fusing bone, for example, fusing vertebrae by securing thearticular processes of the vertebrae. Other embodiments described hereinrelate to augmentation and restoration of vertebral facet jointsaffected by degeneration and the surgical method and devices forimplanting these devices in the spine

Traumatic, inflammatory, and degenerative disorders of the spine canlead to severe pain and loss of mobility. One source of back and spinepain is related to degeneration of the facets of the spine or facetarthritis. Bony contact or grinding of degenerated facet joint surfacescan play a role in some pain syndromes. While many technologicaladvances have focused on the intervertebral disc and artificialreplacement or repair of the intervertebral disc, little advancement infacet repair has been made. Facet joint and disc degeneration frequentlyoccur together. Thus, a need exists to address the clinical concernsraised by degenerative facet joints.

The current standard of care to address the degenerative problems withthe facet joints is to fuse the two adjacent vertebrae. By performingthis surgical procedure, the relative motion between the two adjacentvertebrae is stopped, thus stopping motion of the facets and anypotential pain generated as a result thereof. Procedures to fuse twoadjacent vertebrae often involve fixation and/or stabilization of thetwo adjacent vertebrae until the two adjacent vertebrae fuse. Commonlyowned U.S. Patent Publications 2012/0221049 (U.S. application Ser. No.13/403,698, filed Feb. 23, 2012) and U.S. Pat. No. 8,740,949 (U.S.application Ser. No. 13/033,791, filed Feb. 24, 2011) describe methodsfor stabilizing two bone portions by extending a flexible fastening bandthrough a lumen in two bone portions. The flexible fastening band can beadvanced through a fastener until the two bone portions are stabilized.In one embodiment, the first bone portion is the articular process of afirst vertebrae and the second bone portion is an articular process of asecond vertebra. As described in these applications, in certainembodiments it is useful to dispose prosthesis (e.g., an allograft,metallic implant, etc.) between the first and second bone portionsbefore stabilizing the two bone portions.

Commonly owned U.S. Pat. No. 7,846,183 (U.S. application Ser. No.10/865,073, filed Jun. 10, 2004) describes a method in which the facetjoint is restored by inserting a prosthesis between bone portions, suchas a facet joint. Such a procedure can alleviate the bone on bonecontact that is common in degenerative facet joints and often the sourceof pain generation, while allowing relative motion between the facets tocontinue post-operatively.

Injuries and/or surgical procedure on and/or effecting other bones canalso result in the desire to fixate and/or stabilize a bone until thebone, or bone portions, can fuse, for example, to stabilize a sternumafter heart surgery, to stabilize a rib after a break, etc. Currentprocedures to fixate and/or stabilize adjacent vertebrae and/or otherbones can be slow and/or complex.

Accordingly, a need exists for an apparatus and a procedure to quicklyand/or easily stabilize and/or fixate a bone.

SUMMARY

In some embodiments, a method of placing an implant between a first boneportion and a second bone portion is provided. The method can includethe step of forming a lumen in a first bone portion. The method caninclude the step of forming a lumen in a second bone portion. The methodcan include the step of inserting a trial implant between the first boneportion and the second bone portion. The method can include the step ofinserting a portion of a flexible member through the lumen in the firstbone portion, through the trial implant, and through the lumen in thesecond bone portion. The method can include the step of withdrawing thetrial implant and the flexible member from between the first and secondbone portions. The method can include the step of coupling an implantwith the flexible member. The method can include the step of advancingthe implant between the first and second bone portions.

In some embodiments, the first bone portion is a first articular processand the second bone portion is a second articular process. The methodcan include the step of tying ends of the flexible member together. Insome embodiments, the step of coupling an implant with the flexiblemember can include the step of passing the flexible member through ahole in the implant. In some embodiments, the step of coupling animplant with the flexible member can include the step of passing theflexible member through a slot extending from the edge of the implant.In some embodiments, the implant comprises an allograft. The method caninclude the step of sizing the implant to fit into the joint spacebetween the first bone portion and the second bone portion. In someembodiments, the step of forming a lumen in a first bone portion caninclude drilling a hole. In some embodiments, the step of withdrawingthe flexible member from between the first and second bone portion caninclude bringing the flexible member out at a joint line. The method caninclude the step of inserting the trial implant between the first boneportion and the second bone portion before forming a lumen in the firstbone portion and forming a lumen in the second bone portion. In someembodiments, the step of advancing the implant between the first andsecond bone portions can include applying tension to both ends of theflexible member. The method can include the step of inserting a flexibleretention member through the first bone portion, the implant, and thesecond bone portion and using the flexible retention member to securethe first bone portions and the second bone portions. In someembodiments, the flexible retention member comprises a ratchet.

In some embodiments, a method of placing an implant in a spine facetjoint is provided. The method can include the step of drilling a holeacross the facet joint. The method can include the step of inserting atrial implant in the joint space. The method can include the step ofpassing a flexible member through the hole and across the facet joint.The method can include the step of withdrawing the flexible member outof the facet joint at a joint line by withdrawing the trial implant. Themethod can include the step of coupling an implant with the flexiblemember. The method can include the step of pulling the ends of theflexible member to reduce implant into the joint space. In someembodiments, implant comprises an allograft. The method can include thestep of sizing the implant to fit into the joint space.

In some embodiments, an implant for placement between a first boneportion and a second bone portion is provided. The implant can include abody that is sized to fit in the facet joint of a spine. In someembodiments, the body formed from artificial materials, allograft or acombination thereof. The implant can include the body having a slotextending from an edge of the body to a hole. In some embodiments, theslot and the hole are configured to slidingly accept a flexible member.

In some embodiments, a kit for placement of an implant between two boneportions is provided. The kit can include a trial member with an openingconfigured to engage a flexible member. The kit can include a drillconfigured to form an opening between two bone portions. In someembodiments, the drill is configured to drill a hole when the trialmember inserted between the two bone portions. The kit can include animplant with an opening configured to engage the flexible member. Thekit can include a flexible member. The kit can include a flexiblefastening band through with fastener. In some embodiments, the implantcomprises an allograft.

For purposes of summarizing the invention and the advantages achievedover the prior art, certain objects and advantages of the invention havebeen described herein above. Of course, it is to be understood that notnecessarily all such objects or advantages may be achieved in accordancewith any particular embodiment of the invention. Thus, for example,those skilled in the art will recognize that the invention may beembodied or carried out in a manner that achieves or optimizes oneadvantage or group of advantages as taught or suggested herein withoutnecessarily achieving other objects or advantages as may be taught orsuggested herein.

All of these embodiments are intended to be within the scope of theinvention herein disclosed. These and other embodiments will becomereadily apparent to those skilled in the art from the following detaileddescription of the preferred embodiments having reference to theattached figures, the invention not being limited to any particularpreferred embodiment(s) disclosed.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features, aspects, and advantages of the inventiondisclosed herein are described below with reference to the drawings ofpreferred embodiments, which are intended to illustrate and not to limitthe invention.

FIG. 1 is a lateral elevational view of a portion of the vertebralcolumn.

FIG. 2A is a schematic superior view of an isolated thoracic vertebra.

FIG. 2B are schematic side view of an isolated thoracic vertebra.

FIG. 3A is a schematic posterior elevational view of a portion of thevertebral column.

FIG. 3B is a posterior-oblique elevational view of a portion of thevertebral column.

FIG. 4A is a schematic side view of a facet joint in the cervicalvertebrae.

FIG. 4B is a schematic superior view of a facet joint in the cervicalvertebrae.

FIG. 5A is a schematic side view of a facet joint in the thoracicvertebrae.

FIG. 5B is a schematic superior view of a facet joint in the thoracicvertebrae.

FIG. 6A is a schematic side view of a facet joint in the lumbarvertebrae.

FIG. 6B is a schematic superior view of a facet joint in the lumbarvertebrae.

FIG. 7 is a block diagram of a flexible fastening band according to anembodiment.

FIGS. 8-10 are posterior perspective views of a portion of the vertebralcolumn depicting a method of stabilizing a vertebra using a flexiblefastening band according to an embodiment.

FIG. 11 is a flow chart illustrating a method of inserting an implantbetween two bone portions.

FIG. 12 is a flow chart illustrating a method of inserting an implantinto a facet joint.

FIG. 13 is a schematic view of one embodiment of a trial member having atrial implant deployed in a facet joint.

FIG. 14 is a schematic view of one embodiment of a tool guided over thetrial member of FIG. 13.

FIGS. 15A-15B are posterior perspective views of a portion of thevertebral column depicting a method of using the tool of FIG. 14 todrill through the facet joint.

FIGS. 16A-16B are posterior perspective views of a portion of thevertebral column depicting a method of passing a flexible member throughthe facet joint.

FIG. 17 is a posterior perspective view of a portion of the vertebralcolumn depicting a method of pulling the flexible member of FIGS.16A-16B out of the facet joint using the trial member.

FIG. 18 is a posterior perspective view of a portion of the vertebralcolumn depicting a method of disassembling the trial member.

FIG. 19 is a posterior perspective view of a portion of the vertebralcolumn depicting a method of loading an implant onto the flexiblemember.

FIGS. 20A-20B are posterior perspective views of a portion of thevertebral column depicting a method of pulling the implant of FIG. 19into the facet joint by making the flexible member taut.

FIG. 21 is a posterior perspective view of a portion of the vertebralcolumn depicting a method of cinching the facet joint closed using aflexible fastening band.

FIG. 22 is a block diagram of a kit according to an embodiment.

DETAILED DESCRIPTION

Although certain preferred embodiments and examples are disclosed below,it will be understood by those in the art that the invention extendsbeyond the specifically disclosed embodiments and/or uses of theinvention and obvious modifications and equivalents thereof. Thus, it isintended that the scope of the invention herein disclosed should not belimited by the particular disclosed embodiments described below.

As used in this specification, the singular forms “a,” “an” and “the”include plural referents unless the context clearly dictates otherwise.Thus, for example, the term “an implant” is intended to mean a singleimplant or a combination of implants. As used in this specification, asubstance can include any biologic and/or chemical substance, including,but not limited to, medicine, adhesives, etc. While exemplary referencesare made with respect to vertebra, in some embodiments another bone orportions of bones can be involved. While specific reference may be madeto a specific vertebra and/or subset and/or grouping of vertebrae, it isunderstood that any vertebra and/or subset and/or grouping, orcombination of vertebrae can be used.

As shown in FIG. 1, the vertebral column 2 comprises a series ofalternating vertebrae 4 and fibrous discs 6 that provide axial supportand movement to the upper portions of the body. The vertebral column 2typically comprises thirty-three vertebrae 4, with seven cervical(C1-C7), twelve thoracic (T1-T12), five lumbar (L1-15), five fusedsacral (S1-S5) and four fused coccygeal vertebrae. FIGS. 2A and 2Bdepict a typical thoracic vertebra. Each vertebra includes an anteriorbody 8 with a posterior arch 10. The posterior arch 10 comprises twopedicles 12 and two laminae 14 that join posteriorly to form a spinousprocess 16. Projecting from each side of the posterior arch 10 is atransverse 18, superior 20 and inferior articular process 22. The facets24, 26 of the superior 20 and inferior articular processes 22 form facetjoints 28 with the articular processes of the adjacent vertebrae (seeFIGS. 3A and 3B). The facet joints are true synovial joints withcartilaginous surfaces and a joint capsule.

The orientation of the facet joints vary, depending on the level of thevertebral column. In the C1 and C2 vertebrae, for example the facetjoints are parallel to the transverse plane. FIGS. 4A to 6B depictexamples of the orientations of the facet joints at different levels ofthe vertebral column. In the C3 to C7 vertebrae examples shown in FIGS.4A and 4B, the facets are oriented at a 45-degree angle to thetransverse plane 30 and parallel to the frontal plane 32, respectively.This orientation allows the facet joints of the cervical vertebrae toflex, extend, lateral flex and rotate. At a 45-degree angle in thetransverse plane 30, the facet joints of the cervical spine can guide,but do not limit, the movement of the cervical vertebrae. FIGS. 5A and5B depict examples of the thoracic vertebrae, where the facets areoriented at a 60-degree angle to the transverse plane 30 and a 20-degreeangle to the frontal plane 32, respectively. This orientation is capableof providing lateral flexion and rotation, but only limited flexion andextension. FIGS. 6A and 6B illustrate examples of the lumbar region,where the facet joints are oriented at 90-degree angles to thetransverse plane 30 and a 45-degree angle to the frontal plane 32,respectively. The lumbar vertebrae are capable of flexion, extension andlateral flexion, but little, if any, rotation because of the 90-degreeorientation of the facet joints in the transverse plane. The actualrange of motion along the vertebral column can vary considerably witheach individual vertebra.

In addition to guiding movement of the vertebrae, the facet joints alsocontribute to the load-bearing ability of the vertebral column. Onestudy by King et al. Mechanism of Spinal Injury Due to CaudocephaladAcceleration, Orthop. Clin. North Am., 6:19 1975, found facet jointload-bearing as high as 30% in some positions of the vertebral column.The facet joints may also play a role in resisting shear stressesbetween the vertebrae. Over time, these forces acting on the facetjoints can cause degeneration and arthritis.

Flexible Fastening Band

In some embodiments described herein, a flexible fastening band can beused to stabilize and/or fixate a first vertebra to a second vertebra toreduce the pain, to reduce further degradation of a spine, or of aspecific vertebra of a spine, and/or until the first vertebra and thesecond vertebra have fused. FIG. 7 depicts a block diagram of a flexiblefastening band (“band”) 140. Band 140 includes a flexible elongate bodyincluding a proximal end portion 142, a first portion 144, a secondportion 146, and a distal end portion 148 that includes a fasteningmechanism 150 (alternatively referred to herein as a fastener). In someembodiments, band 140 can include a third portion (not shown in FIG. 7).In some embodiments, band 140 can include a spacer (not shown in FIG.7). In some embodiments, the fastening mechanism can be separate fromthe distal end portion. Band 140 can be configured to stabilize a firstvertebra (not shown in FIG. 7) and/or a second vertebra (not shown inFIG. 7). Specifically, band 140 can be configured to stabilize the firstvertebra and/or second vertebra by securing an articular process of thefirst vertebra to an articular process of a second vertebra. Morespecifically, band 140 can be configured to stabilize the first vertebraand/or a second vertebra by securing an articular process of the firstvertebra to an articular process of a second vertebra by securing afacet of the articular process of the first vertebra with a facet of thearticular process of the second vertebra. In some embodiments, band 140can be removed from the vertebra, e.g. by cutting, breaking, orotherwise releasing band 140. In this manner, should a band fail, areplacement band can be inserted. Similarly, should the band be deemedineffective for a particular patient, the band can be removed and analternate treatment can be chosen without incurring permanent fusion ofthe vertebra. As will be described in more detail herein, band 140 canbe monolithically formed or separately formed. Band 140 can include anybiocompatible material, e.g., stainless steel, titanium, PEEK, nylon,etc.

Proximal end portion 142 is configured to pass through a lumen formedthrough a vertebra and a lumen formed through an adjacent vertebra, andto pass through fastening mechanism 150 of the distal end portion 148.In some embodiments, proximal end portion 142 can be shaped to increasethe ease of inserting proximal end portion 142 into fastening mechanism150, e.g., proximal end portion 142 can be tapered, rounded, and/orangled, etc., to reduce at least a portion of a cross-sectional area ofproximal end portion 142.

First portion 144 can extend for a length between proximal end portion142 and second portion 146, and can have a substantially uniform shape.The first portion 144 can have, for example, a substantially cuboidalshape, or a substantially cylindrical shape. In some embodiments, thelength of first portion 144 can be more than twice the length of secondportion 146. In some embodiments, the cross-sectional area of the firstportion 144 can be smaller than the cross-sectional area of the secondportion 146. In some embodiments, the cross-sectional area of firstportion 144 can be less than a cross-sectional area of a lumen definedby the fastening mechanism 150. First portion 144 can include a gearrack (not shown in FIG. 7) configured to engage a ratchet (not shown inFIG. 7) of the fastening mechanism 150. The gear rack can be configuredto allow first portion 144 to travel through fastening mechanism 150 inonly one direction. First portion 144 can be monolithically formed withsecond portion 146. In some other embodiments, the first portion can beseparately formed from the second portion. First portion 144 can beconfigured to be slideably disposed in a lumen of second portion 146.

Second portion 146 can have a length between first portion 144 anddistal end portion 148, and can include a substantially uniform shape.In embodiments including the third portion, second portion 146 can havea length between first portion 144 and the third portion. Second portion146 can have, for example, a substantially cuboidal shape or asubstantially cylindrical shape. First portion 144 and second portion146 can have the same or different shapes, e.g., first portion 144 andsecond portion 146 can both be substantially cuboidal (see, e.g., band240 in FIG. 8), first portion 144 and second portion 146 can both besubstantially cylindrical, first portion 144 can be substantiallycuboidal while second portion 146 can be substantially cylindrical, orfirst portion 144 can be substantially cylindrical while second portion146 can be substantially cuboidal (not shown). In some embodiments, thelength of second portion 146 can be less than half the length of firstportion 144. In some embodiments, the cross-sectional area of the secondportion 146 can be greater than the cross-sectional area of the firstportion 144. In some embodiments, the cross-sectional area of secondportion 146 can be greater than a cross-sectional area of a lumendefined by the fastening mechanism 150. In this manner, as a portion ofband 140 is advanced through fastening mechanism 150, thecross-sectional area of second portion 146 can prevent band 140 fromadvancing beyond the first portion 144. Second portion 146 can include agear rack (not shown in FIG. 7) configured to engage the ratchet of thefastening mechanism 150. The gear rack can be configured to allow secondportion 146 to travel through fastening mechanism 150 in only onedirection. Second portion 146 can be monolithically formed with firstportion 144. In some embodiments, the second portion can be separatelyformed from the first portion. Second portion 146 can define a lumenconfigured to slideably accept first portion 144.

Distal end portion 148 includes a fastening mechanism 150 configured toaccept at least a portion of proximal end portion 142, first portion144, and/or second portion 146. In some embodiments, distal end portion148, second portion 146, first portion 144, and proximal end portion 142can be monolithically formed. Fastening mechanism 150 includes a lumen(not shown in FIG. 7) configured to accept at least a portion ofproximal end portion 142, a portion of first portion 142, and/or aportion of second portion 146. In some embodiments, the cross-sectionalarea of the lumen of fastening mechanism 150 is smaller than thecross-sectional area of second portion 146. In this manner, secondportion 146 can be prevented from advancing through fastening mechanism150.

In some embodiments, at least one of distal end portion 148, secondportion 146, first portion 144, and proximal end portion 142 can beformed separately from the other(s) of distal end portion 148, secondportion 146, first portion 144, and proximal end portion 142. Saidanother way, and by way of example, distal end portion 148, firstportion 144, and proximal end portion 142 can be monolithically formedtogether, while second portion 146 can be separately formed. In thismanner, band 140 can include an initial second portion 146 configured tobe replaced and/or covered with a replacement second portion 146. By wayof a first example, initial second portion 146 can be monolithicallyformed with first portion 144 and replacement second portion 146 can beslideably disposed over initial second portion 146. By way of a secondexample, initial second portion 146 can be separately formed from firstportion 144, can be removed from band 140, and replacement secondportion 146 can be slideably disposed over first portion 144. By way ofa third example, initial second portion 146 can be separately ormonolithically formed from first portion 144, and replacement secondportion 146 can be slideably disposed over first portion 144 and initialsecond portion 146. In some embodiments, initial second portion 146 andreplacement second portion 146 can have the same shape, e.g., initialsecond portion 146 can include a substantially cylindrical shape andreplacement second portion 146 can include a substantially cylindricalshape. In some embodiments, initial second portion 146 and replacementsecond portion 146 can have different shapes, e.g., initial secondportion 146 can include a substantially cuboidal shape and replacementsecond portion 146 can include a substantially cylindrical shape.

In some embodiments, the shape of first portion 144 and the shape ofsecond portion 146 can be determined based on the shape of an artificiallumen formed through an articular process of a vertebra. By way ofexample, if the shape of the artificial lumen is cuboidal, the shape ofthe first portion 144 and the shape of the second portion 146 can becuboidal to allow the first portion 144 and the second portion 146 toslideably advance through the artificial lumen. By way of a secondexample, if the shape of the artificial lumen is cylindrical, the shapeof the first portion 144 and the shape of the second portion 146 can beeither cuboidal or cylindrical. Continuing with the second example, theshape of the first portion 144 can be cuboidal to allow the firstportion 144 to advance easily through the artificial lumen, while theshape of the second portion 146 can be cylindrical to allow the secondportion 146 to fit more tightly within the artificial lumen as comparedto a cuboidal shape.

In some embodiments, the shape of the first portion 144 and the shape ofthe second portion 146 can be determined based on characteristics of thebone or bone portion against which the first portion 144 and the secondportion 146 may contact. By way of example, while first portion 144and/or second portion 146 can be substantially cuboidal, edges of thefirst portion 144 and/or the second portion 146 can be rounded,partially rounded, and/or otherwise shaped to compliment the shape of abone or bone portion, and/or to reduce digging or grinding into the boneor bone portion. In this manner, use of band 140 may cause little or nodamage to the bone or bone portions contacted by band 140.

In some embodiments, band 140 can include a third portion (not shown inFIG. 7). The third portion can have a length between second portion 146and distal end portion 150, and can have a substantially uniform shape.In some embodiments, the third portion can have, for example, asubstantially cuboidal shape or a substantially cylindrical shape. Insome embodiments, the length of the third portion can be less than halfthe length of first portion 144. The third portion can be monolithicallyformed with first portion 144 and/or the second portion 146. In someother embodiments, the first portion can be separately formed from thesecond portion and/or the first portion.

While each of first portion 144, second portion 146, and the thirdportion can be a substantially uniform shape, in some embodiments anyone of first portion 144, second portion 146, and the third portion caninclude a transition portion to transition band 140 from a firstsubstantially uniform shape to a second substantially uniform shape. Byway of example, in some embodiments, first portion 144 and the thirdportion can be substantially cuboidal and second portion 146 can besubstantially cylindrical. In this example, second portion 146 caninclude an angled, conical, or other shaped transition portion.

FIGS. 8-10 show posterior perspective views of a portion of thevertebral column during a method for stabilizing adjacent vertebraeusing a flexible fastening band (“band”) 240 according to an embodiment.As shown in FIG. 8, a band 240 can be used to stabilize a vertebra V1and vertebra V2 via the inferior articular process IAP1A of vertebra V1and the superior articular process SAP2A of vertebra V2. Also as shownin FIG. 8, a flexible fastening band (“band”) 340 is used to stabilize avertebra V1 and vertebra V2 via the inferior articular process IAP1B ofvertebra V1 and the superior articular process SAP2B of vertebra V2. Insome embodiments, vertebra V1 and/or vertebra V2 are stabilized usingonly one of band 240 or band 340. In some such embodiments, one of band240 or band 340 can be used to stabilize vertebra V1 and/or vertebra V2via one of via the inferior articular process IAP1A of vertebra V1 andthe superior articular process SAP2A of vertebra V2, or, via theinferior articular process IAP1B of vertebra V1 and the superiorarticular process SAP2B of vertebra V2. In other such embodiments, oneof band 240 or band 340 can be used to stabilize vertebra V1 and/orvertebra V2 via both of the inferior articular process IAP1A of vertebraV1 and the superior articular process SAP2A of vertebra V2, and, theinferior articular process IAP1B of vertebra V1 and the superiorarticular process SAP2B of vertebra V2.

Each of band 240 and band 340 can be similar to band 140 described aboveand can include similar components. By way of example, band 240 includesa proximal end portion 242, a first portion 244, a second portion 246,and a distal end portion 248 including a fastening mechanism 250, andband 340 includes a proximal end portion (not shown in FIG. 8), a firstportion, a second portion, and a distal end portion including afastening mechanism. As shown in FIGS. 8-10, the shapes of first portion244, the first portion of band 340, second portion 246, and the secondportion of band 340 can all be cuboidal. As shown in FIG. 8, band 240includes a gear rack 247 and gears 264. Each of gears 264 can be wedgeshaped to allow each of gears 264 to displace the ratchet of fasteningmechanism 250 in only one direction. In some embodiments, gears 264 canbe other shapes, such as blocks, etc.

Additional description, modified and alternative embodiments of theflexible fastening band and methods of installing and using such a bandcan be found in U.S. Pat. No. 8,740,949 (U.S. application Ser. No.13/033,791, filed Feb. 24, 2011) and U.S. Patent Publication2012/0221049 (U.S. application Ser. No. 13/403,698, filed Feb. 23,2012), which are hereby bodily incorporated by reference.

Method and Apparatus for Placement of Device Between Bone Portions

FIG. 11 depicts a flow chart illustrating a method 1000 of placing animplant between two bone portions. Prior to use of the implant, apatient can be prepared for surgery. Some examples of preparations forsurgery are shown and described in U.S. Publication 2011/0040301(application Ser. No. 12/859,009, filed Aug. 18, 2010) and U.S. Pat. No.7,846,183 (application Ser. No. 10/865,073, filed Jun. 10, 2004). Inaddition to those procedures described in this application and othersincorporated by reference, in some embodiments, the surgical procedurecan include direct visualization of the vertebra(e) to be stabilized.Said another way, the medical practitioner can perform the operationwithout the use of fluoroscopy, and, in this manner, may not have torely on the inaccuracies and/or inconvenience inherent in fluoroscopicprocedures. This direct visualization can be possible due to the smallincision necessary for implantation of the band, for example, less thanabout 25 mm, and due to the ease of implanting and deploying the band.In some embodiments, the surgical procedure used can include forming anopening in body tissue. In some embodiments, this opening issubstantially equidistant between a first articular process of the firstvertebra and a second articular process of the first vertebra. A cannula(not shown) can be inserted through the opening and a proximal end ofthe cannula can be positioned near the lumen of superior articularprocess SAP2A of vertebra V2.

Step 1002 can include forming a lumen across two bone portions. A drillor other device (e.g., tissue punch or reamer) can be used to form alumen across two bone portions. In some embodiments, the two boneportions are facets. This step can involve forming a lumen in superiorarticular process SAP2A of vertebra V2 and inferior articular processIAP1A of vertebra V1. For example, the drill can be used to form thelumen in a facet of superior articular process SAP2A of vertebra V2 andform the lumen in a facet of inferior articular process IAP1A ofvertebra V1. Methods and devices for forming lumens in vertebra aredescribed in U.S. Pat. No. 7,846,183 (application Ser. No. 10/865,073,filed Jun. 10, 2004) and U.S. Patent Publication No. 2011/0040301(application Ser. No. 12/859,009, filed Aug. 18, 2010), which are herebybodily incorporated by reference herein. A flexible member, such as asuture, can be positioned within the cannula and can be advanced throughthe cannula until the proximal end portion of the flexible member ispositioned near the lumen of superior articular process SAP2A ofvertebra V2.

Step 1004 can include inserting a portion of the flexible member throughthe lumen and across the two bone portions. The flexible member can beinserted into and through the lumen of the first bone portion. Theflexible member can be inserted into and through the lumen of the secondbone portion. The flexible member has two ends. In some embodiments, thefirst end is threaded consecutively through the first bone portion andthrough the second bone portion. After the threading, one end of theflexible member extends beyond the first bone portion and the other endof the flexible member extends beyond the second bone portion. In someembodiments, the two bone portions are facets. The proximal end portionof the flexile member can be inserted into the lumen of superiorarticular process SAP2A of vertebra V2 and through the lumen of inferiorarticular process IAP1A of vertebra V1. After the threading, one end ofthe flexible member extends beyond the superior articular process andthe other end of the flexible member extends beyond the inferiorarticular process.

Step 1006 can include coupling a portion of the flexible memberextending across to bone portions to the implant. This step may includewithdrawing a portion of the flexible member out of the joint. In someembodiments, the flexible member is coupled to a trial implant when theflexible member is withdrawn. This step can include bringing theflexible member out at a joint line. In some embodiments, the boneportions are facets. This step may include withdrawing a portion of theflexible member from the facet joint. An implant is coupled to theflexible member. In some embodiments, the implant can be coupled to theflexible member by sliding the implant onto the flexible member. Theimplant can include an engagement feature extending from the edge of theimplant to the center of the implant. The engagement feature may be slotconnected to an aperture. The slot may be linear or non-linear. Anon-linear slot may prevent accidental disengagement between the implantand the flexible member. During step 1006, the flexible member remainsthreaded through the lumen in the first bone portion and the lumen ofthe second bone portion.

Step 1008 can include inserting the implant into the space between thebone portions. In some embodiments, the implant is inserted into thejoint space between facet joints. In some embodiments, tension isapplied to both ends of flexible member. The tension takes up slack inthe flexible member, urging the implant into the joint space. Tensioncan be applied until the shortest distance of the flexible member isbetween the first bone portion and the second bone portion. The implantcan be positioned such that the aperture of the implant forms a pathbetween the first bone portion and the second bone portion.

With the implant between two bone portion, for example within the facetjoint, a band can inserted into and through the lumen in first boneportion, into and through the aperture in the implant, and into andthrough the lumen in the second bone portion. The band or otherretaining member can be advanced through a fastening mechanism until thetwo bone portions are stabilized as described in U.S. Patent PublicationNo. 2012/0221049 (U.S. application Ser. No. 13/403,698, filed Feb. 23,2012) and U.S. Pat. No. 8,740,949 (U.S. application Ser. No. 13/033,791,filed Feb. 24, 2011). In such embodiments, the band can extend throughthe implant. The flexible member can be cut to reduce the size theflexible member. In some embodiments, the ends of the flexible membercan be tied to secure the implant within the joint.

FIG. 12 is a flow chart illustrating a method of placing an implantwithin a facet joint. FIG. 12 shows a similar method to FIG. 11, whereinthe first bone portion is a first facet and the second bone portion is asecond facet. With respect to FIGS. 11 and 12 and the associateddescription above, it should be appreciated that not all steps arenecessary and/or that the order of the steps rearranged and/or combined.For example, in certain arrangements, the flexible member can beextended across the facet joint (or two bone portions) while the lumenis being formed.

FIGS. 13-21 illustrate various method steps wherein the first boneportion is a first facet and the second bone portion is a second facet.As described above, prior the illustrated steps, a patient can beprepared for surgery and access can be provided to the treatment site.

FIG. 13 shows the trial member 500 inserted into the patient. In someembodiments, a trial implant 502 is inserted in the facet joint spacebetween the articular processes 20, 22. In some embodiments, the trialimplant 502 is inserted after the facet joint has been incised and thearticular surfaces prepared. The trial implant 502 can be used as areference to size an implant 40 which will be fitted into the jointspace. When the trial implant 502 is inserted in the facet joint, theshaft 504 extends outward from the facet joint 28.

The trial member 500 can include a notch 512 on the proximal end of theshaft 504 to secure the trial member 500 to a tool 400 via a retentionmember. The trial implant 502 can comprise a disk-like member having anaperture 508. The trial implant 502 can have a curved or cupped shape tofacilitate positioning between the articular processes 20, 22. In someembodiments, the trial implant 502 may have different shapes, sizes andthicknesses for use with different sized vertebra.

Some embodiments comprise tools and methods for creating holes or lumensthrough one or more bone portions such as the articular processes 20, 22of the vertebra to facilitate implantation of the implant 40. In someembodiments, the holes or lumens have a curved or non-linearconfiguration. The curved or non-linear configuration allows relativelygreater penetration through the thicker portions of the articularprocess(es) and therefore the articular process(es) may be less likelyto fracture during formation of the hole or lumen. While variousinstruments have been proposed for drilling into and through bone,including for example, the curved drills described in U.S. Pat. Nos.5,700,265, 6,419,678, and 6,607,530, herein incorporated by reference intheir entirety, the subject tool offers the benefits of lumen formationthrough the articular processes within the limited surgical accessavailable about the vertebra. The devices described herein may utilizeone or more curved punch members or curved drills that rotate about anaxis that is transverse to the movement plane of the curved punch orcurved drill member. Unlike traditional orthopedic procedures thatrequire unimpeded access to the surgical site due to thelongitudinally-oriented surgical tools, the curved punch or curved drillmembers also permit access using a limited space or cavity around thearticular processes. As used herein, the terms “lumen-forming” and“lumen formation” refer to the creation of a hole, passageway orindentation generally such as by, for example, piercing, punching,boring, puncturing, or drilling.

FIG. 14 shows the tool 400 coupled to the trial member 500. Oneembodiment of the tool 400, shown in FIG. 14, comprises a shaft 402 witha proximal handle 404 and a distal arm guide 406. The arm guide 406contains a lumen-forming arm 410 (not shown) that can be moved in theproximal-distal direction by manipulation of a proximal actuator 422.The distal portion also comprises an opposing target member 408 having atarget plate 414. The lumen-forming arm 410 comprises a rotating drillbit 412 (not shown) that can be connected to a drill motor by a drillcoupler 424 disposed toward the proximal end of the tool 400. A trialmember 500 with a trial implant 502 can be coupled to the tool 400. Thetrial member 500 can be at least partially supported on the tool 400 bya frame 418 and the proximal handle 404. In some embodiments, the trialmember 500 can be secured to the tool 400 by a retention member, whichcan be released by a release button 514.

The lumen-forming arm 410 can be slideably contained within the shaft402 and the arm guide 406. The lumen-forming arm 410 can be movedbetween an advanced configuration, and a retracted configuration, by aproximal actuator 422 that moves the lumen-forming arm 410 axially alongthe shaft 402 of the tool 400. In the embodiment shown, manipulation ofthe actuator 422 causes a longitudinal movement of the lumen-forming arm410. The lumen-forming arm 410 can be straight or curved or acombination of these shapes. The lumen-forming arm 410 may be stiff,bendable, or partially stiff and partially bendable.

In some embodiments, the lumen-forming arm 410 can be sized to be ableto pass through the articular processes 20, 22 of the spine and theresulting hole is sized for a flexible member 30 and/or band 140, 240 tobe inserted. The lumen-forming arm 410 can have a diameter in the rangeof about 1 mm to 5 mm, preferably about 2 mm to 4 mm, and mostpreferably about 3 mm. At an end of the rotating drill bit 412 can be adrill bit tip 413 (not shown) with a cutting surface for creating thelumen in the facets.

A target member 408 having a target plate 414 can be connected to theframe 418. The target plate 414 is in the path of travel of the lumenforming arm 410 and thus the position of the target plate 414 against anarticular process 22 can provide indication to the user of where thelumen forming arm 410 will emerge from the articular processes 20, 22during the drilling procedure. The target member 408 can advantageouslyhelp the user avoid neural or other structures in and around thearticular process 22 by visualizing and understanding the trajectory ofthe lumen forming arm 410 through the articular processes 20, 22. Insome embodiments, the target member 408 can provide some stabilizationof the articular processes 20, 22 as the lumen forming arm 410 passes orcuts through the bone.

The tool 400 can further comprise a trial member 500 that can be coupledto the handle 404. The trial member 500 can comprise a shaft 504 that isconnected by retention member to the tool 400. Preferably, the retentionmember allows the trial member 500 to be detached from and attached tothe facet drill tool 400 with ease. With the trial member 500 in placeand the trial implant 502 in the facet joint 28 as shown in FIG. 13, thetool 400 can be guided over the shaft 504 until the retention memberengages the notch 512 to lock the trial member 500 to the tool 400. Thetrial member 500 has a trial implant 502 at the distal end. The trialimplant 502, in turn, can comprise a disk-like member and an aperture508 that is lined up with the lumen-forming arm 410 to allow the drillbit tip 413 of the lumen-forming arm 410 to penetrate through the bonesand through the aperture 508. The trial implant 502 can have a curved orcupped shape to facilitate positioning between the articular processes20, 22. In some embodiments, the trial implant 502 may have differentshapes, sizes and thicknesses for use with different sized vertebra.

The tool 400 may be used by positioning the anchor portion 426 of an armguide 406 against one bone portion such as the articular process 20 andpositioning the target plate 414 against another bone portion, such asthe articular process 22. The tool 400 can be rotated axially relativeto the trial member 500 to adjust for variations in the native anatomyof the patient. The surgeon may select a particular rotational and/orangular approach to the surgical site, depending upon the particularanatomy of the patient, the extent and location of damage or injury,prior surgery, and other factors known in the art. Additionalembodiments and method related to drilling holes in bones can be foundin U.S. Patent Publication No. 2011/0040301 (application Ser. No.12/859,009, filed Aug. 18, 2010).

In some embodiments, the trial member 500 can rotate about itslongitudinal axis while coupled to the tool 400 to accommodatevariations in the shapes and positions of the articular processes 20,22. The aperture 508 can be sufficiently large to allow thelumen-forming arm 410 to pass through the aperture 508 even when thetrial member 500 is at an angle to the lumen-forming arm 410.

Alternative embodiments and methods of use of various tools aredescribed in commonly owned US. Patent Publication No. 2011/0040301(U.S. application Ser. No. 12/859,009, filed Aug. 18, 2010), which isincorporated by reference. Accordingly, the device and methods hereincan be combined with the devices and methods disclosed in otherapplications incorporated by references.

As shown in FIGS. 15A and 15B, the tool 400 can be used to drill throughthe facet joint thereby forming a lumen that extends across the facetjoint. When the tool 400 is actuated, the drill bit tip 413 can beextended to cut the lumen in the articular process 20. The lumen-formingarm 410 can extend through the aperture 508 in the trial implant 502.Then the lumen-forming arm 410 can continue to extend to the targetplate 414 of the opposing target member 408 to cut a lumen in thearticular process 22. Once the curved hole is formed, the lumen-formingarm 410 can be retracted back through the lumen in the articularprocesses 20, 22.

As shown in FIGS. 16A and 16B, the flexible member 30 can be passedthrough the lumen of the first articular process 20, through theaperture 508 in the trial implant 502, and through the second articularprocess 22. In one arrangement, the proximal end portion of the flexilemember 30 can be inserted into the lumen of superior articular processSAP2A of vertebra V2, through the aperture 508 in the trial implant 502,and through the lumen of inferior articular process IAP1A of vertebraV1. FIG. 16A shows that the flexible member 30 can be inserted throughaperture 508 in the trial implant 502 and the through the lumens of thefacets while the tool 400 is in place. For example, the lumen-formingarm 410 can guide the flexible member 30 through the lumens in thearticular processes 20, 22. In some embodiments, the flexible member 30is inserted through the lumens as the drill bit tip cuts the lumen. FIG.16B shows the flexible member 30 can be inserted through the aperture508 in the trial implant 502 and the through the lumens of the facetsafter the tool 400 is removed. The flexible member 30 can be coupled toa curved needle 32 shown in FIG. 17 or other guiding device tofacilitate insertion of the flexible member 30 through the lumens of thefacets. In both FIGS. 16A and 16B, the trial member 500 remains withinthe patient and the trial implant 502 remains within the facet joint 28while the flexible member 30 is threaded through the articular processes20, 22. One end of the flexible member 30 can extend beyond the firstarticular process 20 and the other end of the flexible member 30 canextend beyond the second articular process 22 as shown in FIG. 17.

FIG. 17 shows the trial implant 502 can be withdrawn from the facetjoint 28. The flexible member 30 is retained within the aperture 508 ofthe trial implant 502 during this step. The shaft 504 can be pulled awayfrom the facet joint 28, thereby withdrawing the trial implant 502.Withdrawing the trial implant 502 causes the flexible member 30 toextend outward and beyond the facet joint 28 as shown. The flexiblemember 30 has sufficient length to extend through both facets as thetrial implant 502 is withdrawn from the facet joint 28. The ends of theflexible member 30 are drawn inward, toward the facet joint 28 as thetrial implant 502 is withdrawn. As shown, the ends of the flexiblemember 30 extend beyond the lumens in the articular processes 20, 22after the trial implant 502 is withdrawn.

As shown in FIG. 18, the trial member 500 can be disassembled. In someembodiments, the trial implant 502 is decoupled from the shaft 504. Thestem 516 of the trial implant 502 can be releasably retained within theshaft 504 during any or all of the previous steps. The stem 516 caninclude a slot 518 extending from an edge of the stem 516 to theaperture 508. The slot 518 may be linear or non-linear. A non-linearslot may prevent accidental disengagement between the trial implant 502and the flexible member 30. In some methods, the trial implant 502 canbe rotated 90 degrees as shown in FIG. 18 to facilitate removal of theflexible member 30 from the trial implant 502. The flexible member 30can be passed from the aperture 508 through the slot 518 toward the edgeof the stem 516. The flexible member 30 can be disengaged from theaperture 508 and the slot 518 thereby freeing the flexible member 30from the trial implant 502. In some embodiments, the trial implant 502includes an engagement feature extending from the edge of the trialimplant 502 to the aperture 508. The engagement feature may be a slot,such as slot 518. In some embodiments, the engagement feature is formedonly after the trial implant 502 is decoupled from the shaft 504. Forinstance, slot 518 can be formed only when the stem 516 is in anexpanded state in which the two halves of the stem 516 are spaced apart.Other designs are contemplated to permit the flexible member 30 fromdisengaging from the trial implant 502.

FIG. 19 shows the implant 40 coupled to the flexible member 30. Aportion of the flexible member 30 extending outward and beyond the facetjoint 28 can be coupled to the implant 40. In some embodiments, theimplant 40 comprises an engagement feature extending from the edge ofthe implant 40 to an aperture 48. The engagement feature may be a slot44, which may be linear or non-linear. A non-linear slot may preventaccidental disengagement between the implant 40 and the flexible member30. Other embodiments are contemplated to engage the flexible member 30with the implant 40. The flexible member 30 can be inserted from theslot 44 to the aperture 48 to couple the implant 40 to the flexiblemember 30.

The implant 40 comprises a body with a least two faces, a first faceadapted to contact a first bone such as the articular surface of onefacet of the facet joint and a second face adapted to contact a secondbone such as the articular surface of the other facet. The aperture 48can be sized and configured to accept a retaining member, such as theretaining members described in U.S. Pat. No. 7,846,183 (U.S. applicationSer. No. 10/865,073, filed Jun. 10, 2004). The aperture 48 can be sizedand configured to accept a band, such as the bands described herein andin U.S. Publication No. 2012/0221060 (U.S. application Ser. No.13/033,791, filed Feb. 24, 2011).

In some embodiments, the implant 40 has a generally circular profile andis sized to fit generally within the joint capsule of the facet joint28. In some embodiments, the implant 40 can be, for example,substantially disc shaped. In other embodiment of the invention, theimplant 40 can have any of a variety of profiles, including but notlimited to square, rectangle, elliptical, oval, star, polygon orcombination thereof. In some embodiments, an implant 40 having thedesired shape is selected from an array of implants after radiographicvisualization of the articular processes and/or by radio-contractinjection into the facet joint to visualize the joint capsule.

In some embodiments, the implant 40 has a diameter of about 4 mm toabout 30 mm. In another embodiment, the implant 40 has a diameter ofabout 5 mm to about 25 mm. In still another embodiment, the implant 40has a diameter of about 10 mm to about 20 mm. In some embodiments, theimplant 40 has a cross-sectional area of about 10 mm² to about 700 mm².In another embodiment, the implant 40 has a cross-sectional area ofabout 25 mm² to about 500 mm². In still another embodiment, the implant40 has a cross-sectional area of about 20 mm² to about 400 mm², andpreferably about 25 mm² to about 100 mm².

The implant 40 has a thickness generally equal to about the anatomicspacing between two facets of a facet joint. In some embodiments, theimplant 40 generally has a thickness within the range of about 0.5 mm toabout 3.0 mm. In some embodiments, the implant 40 has a thickness ofabout 1 mm to about 2 mm. In some embodiments, the implant 40 has athickness of about 0.5 mm to about 1.5 mm. In some embodiments, thethickness of the implant 40 is non-uniform within the same implant. Forexample, the thickness of the implant 40 can be increased around theentire outer edge, along at least one and, as illustrated, both faces.In some embodiments, only a portion of the edge on one face of theimplant 40 has a thickness that is greater than the thickness of acentral region, and, optionally, also thicker than the typical anatomicspacing between two facets of a facet joint. An increased edge thicknessmay resist lateral displacement of the prosthesis out of the facetjoint.

In some embodiments of the invention, the implant 40 is configured toprovide an improved fit with the articular process and/or joint capsule.For example, the implant 40 can have a bend, angle or curve to generallymatch the natural shape of an articular facet. The implant 40 may berigid with a preformed bend. Alternatively, the implant 40 may besufficiently malleable that it will conform post implantation to theunique configuration of the adjacent facet face. In certain embodiments,the implant 40 is configured to be implanted between the articularprocesses and/or within the joint capsule of the facet joint, withoutsecuring of the implant to any bony structures. Such embodiments canthus be used without invasion or disruption of the vertebral bone and/orstructure, thereby maintaining the integrity of the vertebral boneand/or structure.

The implant 40 can be similar to, and have similar features to theembodiments of the prosthesis shown and described in commonly owned U.S.Pat. No. 7,846,183 (application Ser. No. 10/865,073, filed Jun. 10,2004), which is incorporated herein by reference in its entirety. Theimplant 40 can be implanted and deployed to restore the space betweenfacets of a superior articular process of a first vertebra and aninferior articular process of an adjacent vertebra. As described herein,the implant 40 can be deployed to help stabilize adjacent bone portions,such as adjacent facets of a facet joint. A porous surface can allowbone to grow into or attach to the surface of the implant, thus securingthe implant to the bone. In one embodiment, an adhesive or sealant, suchas a cyanoacrylate, polymethylmethacrylate, or other adhesive known inthe art, is used to bond one face of the implant to an articularsurface.

The implant can include a first side and a second side. The first sideand/or the second side can be, for example, convex, concave, or flat.The first side of the implant can be concave, convex, or flat, and thesecond side of the implant can be concave, convex, or flat. For example,the first side can be concave and the second side concave, the firstside can be concave and the second side convex, etc.

In some embodiments, at least a portion of the implant 40 can be formedof allograft. In some embodiments, at least a portion of the implant 40can be formed of artificial materials, such as, for example, titanium orPEEK. In some embodiments, the implant 40 can be deployed to deliverand/or release a substance. In some embodiments, the substance can havetherapeutic properties, for example, a medication. In some embodiments,the substance is an adhesive. The implant 40 can include the samematerials as the flexible band, describe herein. In some embodiments,the implant 40 can increase the stability of a vertebra and/or theflexible band, describe herein.

As described in these applications, U.S. Patent Publication Nos.2012/0221049 (U.S. application Ser. No. 13/403,698, filed Feb. 23, 2012)and 2012/0221060 (U.S. application Ser. No. 13/033,791, filed Feb. 24,2011) in certain embodiments it is useful to dispose the implant 40between the first and second bone portions before stabilizing the twobone portions and/or performing other procedures. Certain aspects of thedescribed herein involve facilitating the insertion of the implant 40between the bone portions. Accordingly, the device as methods herein canbe combined with the devices and methods disclosed in other applicationsincorporated by references.

FIG. 20A shows the implant 40 being inserted into the facet joint. Toreduce the implant 40 into the facet joint, tension can be applied toone or both ends of the flexible member 30. The slot 44 can be orientedaway from the facet joint 28 to prevent accidental disengagement of theflexible member 30 from the implant 40. The tension takes up slack inthe flexible member 30, urging the implant 40 into the joint space.Tension can be applied until the implant 40 is held taut by the flexiblemember 30. The implant 40 can be positioned such that the aperture 48forms a path between the first bone portion and the second bone portion,as illustrated in FIG. 20B. In some embodiments, the flexible member 30is secured to maintain the position of the implant 40. In someembodiments, the ends of the flexible member 30 are secured to eachother or to other objects such as anchors, tacks, or bones. In someembodiments, the ends of the flexible member 30 are tied. In someembodiments, the flexible member 30 is removed. In some embodiments, theends of the flexible member 30 are cut.

As shown in FIG. 21, the facet joint can be stabilized using a band 140,240 as described herein. In some embodiments, the band 140, 240 canfollow the path of the flexible member 30. In some embodiments, theflexible member 30 is removed prior to insertion of the band 140, 240.In other embodiments, the flexible member 30 is removed after toinsertion of the band 140, 240. The band 140, 240 can be extendedthrough the lumen of the first facet, the aperture 48 of the implant 40,and through the lumen in the second facet. The proximal end 142, 242 ofthe band 140, 240 can be advanced through a fastening mechanism 150, 250until the two facets are stabilized.

FIG. 22 illustrates is a block diagram of a kit for inserting an implantinto a facet joint according to an embodiment. The kit 600 can includethe tool 400 as described herein. The kit 600 can include the trialmember 500 including the trial implant 502 and the shaft 504. The kit600 can include the flexible member 30. The kit can include the implant40. In some embodiments, the kit includes two of the components selectedfrom the group of the tool 400, the trial member 500, the flexiblemember 30 and the implant 40. In some embodiments, the kit includesthree of the components selected from the group of the tool 400, thetrial member 500, the flexible member 30 and the implant 40. In someembodiments, the kit includes all of the following components: the tool400, the trial member 500, the flexible member 30 and the implant 40. Insome embodiments, the kit includes multiple implants 40 (e.g., two,three, four, a plurality). In some embodiments, the kit includesmultiple trial members 500 (e.g., two, three, four, a plurality). Insome embodiments, the kit includes multiple trial implants 502 (e.g.,two, three, four, a plurality).

In some embodiments, a method of placing an implant into a facet jointof the spine is provided. The method can include the step of forming ahole across the facet joint. The method can include the step of passinga flexible member through the hole and across the facet joint. Themethod can include the step of bringing the flexible member out of thefacet joint. The method can include the step of coupling an implant tothe flexible member. The method can include the step of tightening theflexible member to reduce into the implant into a joint space.

The method can include the step of cutting the flexible member. Themethod can include the step of tying cut ends of the flexible membertogether. In some embodiments, the flexible member is a suture. In someembodiments, the implant includes a hole for receiving the flexiblemember. In some embodiments, the implant includes a slot for receivingthe flexible member. In some embodiments, the implant includes allograftor an artificial material. In some embodiments, the implant is sized tofit into the joint space. In some embodiments, the step of forming ahole across the facet joint comprises drilling a hole. In someembodiments, the step of bringing the flexible member out of the facetjoint comprises bringing the flexible member out at a joint line. Themethod can include the step of inserting a trial implant into the jointspace before forming a hole across the facet joint. The method caninclude the step of withdrawing the trial implant out of the joint spaceto bring the flexible member out of the facet joint. The method caninclude the step of inserting a flexible retention member through thefacet joint and the implant and using the flexible retention member tosecure the facet joint.

In some embodiments, a method of placing an implant in a spine facetjoint is provided. The method can include the step of drilling a holeacross the facet joint. The method can include the step of removing thedrill. The method can include the step of leaving behind atrial/targeting device in the joint space. The method can include thestep of passing a suture through the hole and across the facet joint.The method can include the step of bringing the suture out of the facetjoint at a joint line by removing the trial/targeting device. The methodcan include the step of removing the suture from the trial/targetingdevice by passing it through a slot in the trial/targeting device. Themethod can include the step of placing an implant with a hole and slotover the suture. The method can include the step of pulling the suturetight to reduce implant into the joint space. In some embodiments, theimplant comprises artificial material and/or allograft. In someembodiments, the implant is configured and sized to fit into the jointspace.

In some embodiments, a device for placement in a spine facet joint isprovided. The device can include a body that is sized to fit in thefacet joint of a spine. In some embodiments, the body is formed fromartificial materials, allograft or a combination thereof. In someembodiments, the body has a hole for receiving a suture or flexiblefixation member. In some embodiments, the body has a slot so that it canbe placed over a portion of the suture or flexible fixation member.

In some embodiments, a kit for placement of an implant into a spinefacet joint is provided. The kit can include a trial member with anopening. The kit can include a drill configured to form an openingbetween two bone portions and the trial member inserted between the twobone portions. The kit can include an implant with an opening. The kitcan include a flexible member. The kit can include a flexible fasteningband through with fastener. In some embodiments, the implant comprisesan allograft.

It should be appreciated that the methods and devices described hereinfor placing an implant into a joint or between two bone portions are notlimited to fusion applications and/or the fusion devices describedherein. For example, the methods and devices described herein forplacing an implant into a joint or between two bone portions can be usedwith fixation devices that utilized flexible fasteners of differentconfiguration and/or fasteners that are not flexible (e.g., rods,screws, and/or clamps) that extend across the joint or between boneportions.

In addition, methods and devices described herein for placing an implantinto a joint or between two bone portions can also be used in non-fusionapplications. For example, U.S. Pat. No. 7,846,183 and/or U.S. Pat. No.8,740,949 (which are incorporated by reference herein) disclose variousdevices and methods for the augmentation and restoration of vertebralfacet joints. Several embodiments involve the insertion of implant(e.g., a disk) into the facet joint. Several embodiments include a holeor slot in the implant and/or a flexible member that can extend acrossan opening formed in the facet joint and the implant. In suchembodiments, the techniques and devices described herein for advancing aflexible member through the facet joint and then using the flexiblemember to urge the implant into the facet joint can be used.

It should also be appreciated that the methods and devices herein arenot limited to the facet joint but can also be used to insert an implantbetween to bone portions and/or other joints in the body.

Although this invention has been disclosed in the context of certainpreferred embodiments and examples, it will be understood by thoseskilled in the art that the present invention extends beyond thespecifically disclosed embodiments to other alternative embodimentsand/or uses of the invention and obvious modifications and equivalentsthereof. In addition, while several variations of the invention havebeen shown and described in detail, other modifications, which arewithin the scope of this invention, will be readily apparent to those ofskill in the art based upon this disclosure. It is also contemplatedthat various combinations or sub-combinations of the specific featuresand aspects of the embodiments may be made and still fall within thescope of the invention. It should be understood that various featuresand aspects of the disclosed embodiments can be combined with, orsubstituted for, one another in order to form varying modes of thedisclosed invention. For all the embodiments described above, the stepsof the methods need not be performed sequentially. Thus, it is intendedthat the scope of the present invention herein disclosed should not belimited by the particular disclosed embodiments described above, butshould be determined only by a fair reading of the claims that follow.

What is claimed is:
 1. A method of placing an implant between a firstbone portion and a second bone portion, the method comprising: forming alumen in a first bone portion; forming a lumen in a second bone portion;inserting a trial implant between the first bone portion and the secondbone portion; inserting a portion of a flexible member through the lumenin the first bone portion, through the trial implant, and through thelumen in the second bone portion; withdrawing the trial implant and theflexible member from between the first and second bone portions;coupling an implant with the flexible member; and advancing the implantbetween the first and second bone portions.
 2. The method of claim 1,wherein the first bone portion is a first articular process and thesecond bone portion is a second articular process.
 3. The method ofclaim 1, further comprising tying ends of the flexible member together.4. The method of claim 1, wherein the step of coupling an implant withthe flexible member comprises passing the flexible member through a holein the implant.
 5. The method of claim 1, wherein the step of couplingan implant with the flexible member comprises passing the flexiblemember through a slot extending from the edge of the implant.
 6. Themethod of claim 1, wherein the implant comprises an allograft or anartificial material.
 7. The method of claim 1, wherein the implant issized to fit into the joint space.
 8. The method of claim 1, whereinforming a hole across the facet joint comprises drilling a hole.
 9. Themethod of claim 1, wherein withdrawing the flexible member from betweenthe first and second bone portion comprises bringing the flexible memberout at a joint line.
 10. The method of claim 1, further comprisinginserting the trial implant between the first bone portion and thesecond bone portion before forming a lumen in the first bone portion andforming a lumen in the second bone portion.
 11. The method of claim 1,wherein advancing the implant between the first and second bone portionscomprises applying tension to both ends of the flexible member.
 12. Themethod of claim 1, further comprising inserting a flexible retentionmember through the first bone portion, the implant, and the second boneportion and using the flexible retention member to secure the first boneportion and the second bone portion.
 13. The method of claim 12, whereinthe flexible retention member comprises a ratchet.
 14. A method ofplacing an implant in a spine facet joint, the method comprising forminga hole across the facet joint; inserting a trial implant in the jointspace; passing a flexible member through the hole and across the facetjoint; withdrawing the flexible member out of the facet joint at a jointline by withdrawing the trial implant; coupling an implant with theflexible member; and pulling the ends of the flexible member to reducethe implant into the joint space.
 15. The method of claim 14, whereinthe implant comprises an allograft.
 16. The method of claim 14, furthercomprising sizing the implant to fit into the joint space.
 17. Animplant for placement between a first bone portion and a second boneportion, the implant comprising: a body that is sized to fit in a facetjoint of a spine, the body formed from artificial materials, allograftor a combination thereof, the body having a slot extending from an edgeof the body to a hole, the slot and the hole configured to slidinglyaccept a flexible member.
 18. A kit for placement of an implant betweentwo bone portions, the kit comprising: a trial member with an openingconfigured to engage a flexible member; a drill configured to form anopening between two bone portions, the drill configured to drill a holewhen the trial member is inserted between the two bone portions; animplant with an opening configured to engage the flexible member; and aflexible member.
 19. The kit of claim 18 further comprising a flexiblefastening band with fastener.
 20. The kit of claim 18, wherein theimplant comprises an allograft.